Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Minnesota
About this trial
The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway.
A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >=65 years
Primary diagnosis of acute infection (per investigator judgment)
SOFA >1
Admission order to the hospital
Disqualifiers
Admission to the ICU
Vasopressors, mechanical ventilation, or dialysis
Comfort care only
Total bilirubin >3X or AST/ALT >4x upper limit of normal
Trial design
Design model
Parallel
Treatments tested in this trial
Fisetin-dose 1
Drug20mg/kg once a day for one day.
Fisetin-dose 2
Drug20mg/kg once a day for two days
Placebo
DrugPlacebo treatment
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: Fisetin- dose 1Experimental treatment 1 intervention
Group B: Fisetin- dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)
The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. This outcome assesses only the cardiovascular, respiratory, and renal categories of the total SOFA score, and calculates the change from day 0 to day 7.
Time frame
day 7Secondary outcomes
1
Safety of 2 doses of fisetin in patients with mild sepsis
Outcome is the number of serious adverse event
Time frame
day 282
Organ failure free days
Outcome is 28 days minus the last day the patient required any of the following: ventilator support, vasopressors, or dialysis / renal replacement therapy. Patients who die prior to day 28 are given a value of -1.
Time frame
day 283
Total SOFA score
The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.
Time frame
day 74
Zubrod performance status
A scale for indicating a patient's functional level: 0 asymptomatic - 1 Symptomatic, fully ambulatory - 2 Symptomatic, in bed - 50% of the day - 3 Symptomatic, in bed; 50% of the day but not bedridden - 4 Bedridden - 5 Dead.
Time frame
day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov